Package 58552-133-04

{"route": ["ORAL"], "spl_id": "40b83871-7eac-3d44-e063-6394a90a2b29", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "unii": ["9D2RTI9KYH", "495W7451VQ"], "rxcui": ["996520"], "spl_set_id": ["852d5f01-9289-5515-e053-2a91aa0acf32"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["Gil Pharmaceutical Corp"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (58552-133-04)  / 118 mL in 1 BOTTLE", "package_ndc": "58552-133-04", "marketing_start_date": "20181002"}], "brand_name": "Giltuss Childrens Cough and Chest Congestion", "product_id": "58552-133_40b83871-7eac-3d44-e063-6394a90a2b29", "dosage_form": "SOLUTION", "pharm_class": ["Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]"], "product_ndc": "58552-133", "generic_name": "Dextromethorphan hydrobromide, Guaifenesin", "labeler_name": "Gil Pharmaceutical Corp", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Giltuss Childrens Cough and Chest Congestion", "active_ingredients": [{"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "10 mg/5mL"}, {"name": "GUAIFENESIN", "strength": "100 mg/5mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20181002", "listing_expiration_date": "20261231"}